Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Alternate Title

Bone Marrow Transplantation in Treating Patients With Metastatic Breast Cancer or Hematologic Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase IV Supportive care, Treatment Closed Any age Other MSGCC-9721 NCI-V98-1438

Objectives

I.  Evaluate a T-cell depletion technique known to prevent graft-versus-host 
disease in patients with leukemia, lymphoma, myelodysplastic syndromes, or 
multiple myeloma undergoing allogeneic bone marrow transplantation (BMT) with 
a matched-related donor.

II.  Evaluate the incidence and quality of engraftment and completeness of 
chimerism in these patients.

III.  Determine the incidence of relapse post-BMT according to stage of the 
disease at the time of BMT.

IV.  Determine the toxicity of this regimen and the incidence and type of 
post-BMT complications in these patients.

V.  Determine the effectiveness of this regimen in patients too old for a 
non-T-cell depleted BMT.

Entry Criteria

Disease Characteristics:

Histologically proven malignancy or condition of any of the following types:
  Acute myelogenous leukemia or acute lymphocytic leukemia
  In first or greater remission OR
  Refractory to first remission induction therapy OR
  In relapse, but with a low tumor load (leukemic index less than 10%)
 Chronic myelogenous leukemia
 Myelodysplastic syndrome
 Aggressive or refractory Hodgkin's disease
 Aggressive or refractory non-Hodgkin's lymphoma
 Multiple myeloma at early relapse or after conventional chemotherapy to      
  reduce tumor mass
 High risk chronic lymphocytic leukemia
 Aplastic anemia
 Metastatic breast cancer refractory to standard chemotherapy

HLA-identical family member available as donor

Hormone receptor status:
 Not specified

Prior/Concurrent Therapy:

Biologic therapy:
 Not specified

Chemotherapy:
 See Disease Characteristics

Endocrine therapy:
 Not specified

Radiotherapy:
 Not specified

Surgery:
 Splenectomy required at least 10 days before study entry for patients with   
  chronic myeloid leukemia

Patient Characteristics:

Age:
 Any age

Menopausal status:
 Not specified

Performance status:
 Karnofsky 70-100%

Life expectancy:
 Greater than 8 weeks

Hematopoietic:
 Not specified   

Hepatic:
 Bilirubin less than 2 mg/dL
 SGOT no greater than 4 times upper limit of normal (ULN)
 No increase in bilirubin or SGOT for at least 2-4 weeks before transplant

Renal:
 Creatinine less than 2 times ULN OR
 Creatinine clearance greater than 60 mL/min

Cardiovascular:
 LVEF greater than 50% by MUGA

Pulmonary:
 DLCO greater than 50%

Other:
 HIV negative
 No active extramedullary disease
 Not pregnant or nursing
 Fertile patients must use effective contraception during and for 1 year after
  transplantation

Expected Enrollment

Approximately 10-20 patients will be accrued for this study per year.

Outline

Patients receive total body irradiation (TBI) three times a day on days -9 to 
-7, followed by 1 fraction on day -6.  Following TBI, patients receive 
thiotepa IV over 4 hours daily on days -5 and -4 plus cyclophosphamide IV over 
1 hour and antithymocyte globulin daily on days -3 and -2.

Patients undergo an allogeneic bone marrow transplantation on day 0.  Bone 
marrow is harvested from the patient's donor, and depleted of T-cells by 
differential agglutination with soybean lectin followed by rosetting with 
sheep red blood cells.  The bone marrow is then infused over 15 minutes.

Trial Contact Information

Trial Lead Organizations

Greenebaum Cancer Center at University of Maryland Medical Center

Guido Tricot, MD, PhD, Protocol chair(Contact information may not be current)		Ph: 410-328-1230; 800-888-8823 Email: gtricot@umcc01.umcc.ab.umd.edu